Gamida Cell Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to GametaCell's conference call for third quarter 2023 financial results. My name is Chris, and I'll be the operator for today's call. Please be advised that this call is being recorded at GametaCell's request. I would now like to introduce your host for today's conference, Mike Koskowski of GametaCell Corporate Communications. Mike, please go ahead.

Thank you, Chris, and good morning, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the third quarter of 2023. Earlier this morning, we issued a press release summarizing our financial results and providing a business update, which is available on our website at www.gametacell.com. Here with me on our call today are Abby Jenkins, President and Chief Executive Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, Ronit Simantov, Chief Medical Officer and Chief Scientific Officer, and Terry Qualio, our Chief Financial Officer. Before we begin, I want to remind everyone that during this call, we may make forward-looking statements about our future expectations and plans, including with respect to the potentially life-saving or curative therapeutic potential of Omisurge, I'm going to do a cell ONLV, the company's cell therapy candidate, GDA201, expectations regarding the commercial launch of Omisurge and potential to capture market share and generate revenue, GametaCell's plans for commercial or strategic partnerships to support the launch of AmaSurge, GametaCell's financial runway, GametaCell's ability to keep its Israel facilities open, the state of its workforce, and future developments that may adversely impact GametaCell's Israel operations. Our actual results may differ materially from what we project today due to a number of important factors, including those related to clinical, scientific, regulatory, and technical developments, and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around our product and product candidate, as well as those considerations described in the risk factors section of our most recent quarterly report on Form 10Q and other filings that we may make with the SEC from time to time. These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information or future events, except as required by applicable law. Now, let me turn the call over to our President and CEO, Abby Jenkins.

Thank you, Mike, and everyone joining us today. I want to begin by providing a brief corporate update. We've made strong progress this quarter, which I'll go into detail on in a moment. But I would be remiss if I didn't start this call by first acknowledging the courage and resilience of our Israeli team members who have shown incredible dedication and commitment to patients as they continue operations to ensure we reliably deliver AmiSurg to patients in need while living and working in a war zone. For patients with hematologic malignancies in need of an allogeneic stem cell transplant, AmiSurg may represent their last or best hope for a cure. and we are proud to be able to continue to serve our patients under these challenging circumstances. Our employees' safety is a key concern, and we are relieved to be able to say everyone remains safe. As you might imagine, the process of getting cells into Israel and delivering OmniSurg back to transplant centers in the U.S. could have been impacted when many airlines suspended flight service in Israel. Our team of dedicated employees did not hesitate to put patients first when their own lives were impacted working diligently to maintain operations and adapting in real time as events unfolded. To see our team members demonstrate such resilience and strength in a challenging environment has been inspiring to witness. Shifting gears and moving on to our corporate updates. Our lean launch has continued to exceed our expectations across the two key metrics we defined for launch, transplant center onboarding and market access for patients. As of this morning, we have onboarded 17 transplant centers, exceeding the top end of our projected goal of 10 to 15 transplant centers for the year. OmniSurg has confirmed coverage with U.S. payers covering more than 90% of commercial lives, exceeding our full-year goal of 70%. This includes confirmed coverage with all of the top 20 U.S. commercial payers. AmiSurg has also confirmed coverage and reimbursement with Medicare for the Centers for Medicare and Medicaid Services. This means the vast majority of patients now have coverage in place for AmiSurg. The third quarter marks the moment GametaCell truly transitioned to a commercial stage company with our first revenue reported. We are so proud to provide AmiSurg a potentially life-saving cell therapy for those in need of a transplant donor source. We are reporting revenue from the delivery of two AMI-surg units in the third quarter and are estimating revenue from the delivery of a total of four to six units of AMI-surg for the full year 2023. The patient volume and AMI-surg unit ramp are aligned with our expectations based on the lean launch model and number of transplant centers onboarded and consistent with other launches in the cell and gene space. We've received very strong feedback from transplant centers on the onboarding process, on GametaCell Assist as a tool and resource, and most importantly, on OmniSurg's ability to fulfill an unmet need. OmniSurg is the first and only true pharmaceutical transplant option approved on the basis of a global randomized phase three trial, and transplanters see its value and potential. As we end 2023 and prepare to enter 2024, we will continue to maintain our lean launch efforts due to resource constraints as we pursue additional funding. The early launch phase of AmiSurg has confirmed our market research insights. There is an unmet need in the market that AmiSurg can fulfill. Rapid transplant center onboarding has proven that transplant centers are interested in making AmiSurg an option for patients with hematologic malignancies. Considering the need to thoughtfully invest based on our cash position, we will be prioritizing virtually all of our resources moving forward to expand patient access to AmiSurg. Assuming our ability to extend our cash runway, we expect to have more than 40 transplant centers onboarded by the end of 2024, including at least half of the top 70 transplant centers in the U.S. To reiterate, we remain committed to our two-pronged corporate strategy announced earlier this year, which involves first launching AmiSurg in the U.S., with a focus on expanding patient access by onboarding transplant centers and ensuring market access coverage and reimbursement. And second, pursuing a strategic partnership or transaction to support fully resourced commercialization of AmiSurg. In terms of our business development activities, our efforts to identify a strategic partner are ongoing. We have received considerable interest from multiple potential partners during the process which has been supported by the leading global independent investment bank, Lolis & Company, and has resulted in oral and written proposals. However, at present, we have not identified a partnership that will adequately address our strategic needs and plan to continue the business development process in 2024. It will be critical for us to ensure we have sufficient capital to execute this two-pronged strategy. A key step in the process was achieved at our recent Annual General Meeting of Shareholders held in October. At this meeting, a majority of shareholders voted to approve six proposals relating to the company's business, including an increase in GametaCell's authorized share capital. This will provide us with the flexibility to continue to finance our operations and enable a potential transaction should one be available to us. So in summary, Our lean launch is proceeding ahead of our expectations, and we expect to maintain our lean launch approach to expand the number of onboarded transplant centers and patients receiving OmniSurg into 2024. We are proud to report our first OmniSurg deliveries, an official transition into being a commercial stage revenue reporting company, expecting to deliver a total of four to six units for the full year 2023. We are seeking the necessary funding to support expanded patient access to AmiSurg and enable a strategic partnership to fully resource commercialization of AmiSurg. I will now turn the call over to Michelle for a more in-depth update on the AmiSurg launch. Michelle, over to you.